BEUDAMED
    FDA Adverse Event Other Summary report: N

    13652067 12" 4-PANEL AB BINDER 46-62

    MDR report key: 392180 · Received May 2, 2002

    Report

    Report Number
    1125634-2002-00006
    Event Type
    Other
    Date Received
    May 2, 2002
    Report Date
    April 26, 2002
    Manufacturer
    DEROYAL INDUSTRIES, INC
    Product Code
    FSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED SKIN IRRITATION WHILE WEARING AN ABDOMINAL BINDER. BINDER FROM THE INCIDENT LOT NUMBER 865660 WAS RETURNED FOR EVAL IN 03/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 13652067 12" 4-PANEL AB BINDER 46-62 TLG TOP-OF-THE-LINE CHEST PRODUCTS FSD DEROYAL INDUSTRIES, INC NA 865660

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other